Feasibility Study for Fibroblast Autologous Skin Grafts: Biopsy of Skin Fibroblasts, Expansion in Cell Therapy Core, Topical Injection of Fibroblasts, and Subsequent Removal of Graft for Laboratory Studies.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cytoplasmic size increase
研究概览
简要总结
This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.
详细描述
To change the skin identity investigators propose to take skin cells from a person's own sole or palm (these are called "autologous skin fibroblasts"), multiply them in the lab, inject the cells (now called a "graft") back into the same person but at a different site of skin like the buttock, and then eventually remove the injected cells to see if they caused the skin to change.
Investigators hope that information from this study will help with problems like skin break-down in patients with amputations and prosthetics. The skin at their stump was not meant to withstand the pressure and friction of prosthetics and this study is the first step in trying to convert stump skin to palm/sole-like skin. In some select subjects the investigators will test if the addition of an FDA approved filler product might enhance cellular efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Sites are labeled as A, B and C and masked for outcomes assessors-- but these are all in the same subject.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •May be male or female
- •Must be between 18 years and 65 years of age
- •In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.
- •Be able to comprehend the informed consent document and provide consent for participation
- •Females of childbearing potential must:
- •have a negative pregnancy test at screening
- •agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
- •be willing to use a reliable form of contraception during the study
- •Have healthy skin as determined by the PI or study Nurse Practitioner.
- •Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.
排除标准
- •Having received any investigational drug within 30 days prior to study entry
- •An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch
- •Pregnant, lactating, or trying to become pregnant
- •A history of keloid formation
- •An active nonhealing wound
- •Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, Human T-lymphotropic virus (HTLV) I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.
- •Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.
- •Having current skin diseases (i.e. extreme and active eczema, psoriasis, lichen planus) that the investigator feels is not safe for study participation
- •A diagnosis of uncontrolled diabetes
- •Active smoker during the study
- •We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
- •Known bovine or meat sensitivity or severe allergies manifested by anaphylaxis to any product
- •Known bleeding disorder
研究组 & 干预措施
autologous skin fibroblasts
The investigators are comparing 3 injection sites in the same individual
干预措施: autologous skin fibroblasts (Biological)
autologous skin fibroblasts
The investigators are comparing 3 injection sites in the same individual
干预措施: Filler Product (Biological)
结局指标
主要结局
Cytoplasmic size increase
时间窗: 6 months
Volar keratinocytes have larger area of the cytoplasm. We will quantitate the area of cytoplasm of non-volar keratinocytes to see if they increase selectively with volar fibroblasts as opposed to other fibroblasts injections or vehicle. The change in the area of cytoplasm of non-volar keratinocytes will be measured. The units of this measurement are a ratio of cytoplasmic area to total cellular area as a control.
次要结局
- Durometer reading(6 months)